Title 201 | Chapter 002 | Regulation 414E
This emergency administrative regulation establishes requirements that the Board of Pharmacy shall implement to comply with 42 U.S.C. 247d-6d, 85 Fed. Reg. 15198, 52136 and 86 Fed. Reg. 9516, 10588,14462 and 41977.These provisions of federal law preempt state law during the public health emergency (PHE). Since March 18, 2020, ten (10) amendments to the Prep Act declaration have been issued, including amendments authorizing pharmacists to prescribe and administer COVID-19 vaccines for individuals as young as three (3). The PHE for COVID-19 ends on May 11, 2023, and under section V(d) and (f) and under section VII(b) of the PREP Act declaration, the expanded authority for pharmacists will expire. This statement of emergency is limited from filing until May 11, 2023. This emergency administrative regulation is necessary, pursuant to KRS 13A.190(1)(a)3 and 4, to ensure continued compliance with federal law and to ensure that Kentucky continues to have an ample pool of pharmacists available to order and administer the COVID-19 vaccine. Without this emergency regulation, many Kentucky-licensed pharmacists would become ineligible to order and to administer the COVID-19 vaccine because they do not meet federal training requirements. So long as the state has a training requirement, compliance with the state training requirement is sufficient to comply with federal law. Without this emergency administrative regulation, there is no state training requirement. An ordinary administrative regulation is not a sufficient avenue to address the current emergency due to the COVID-19 pandemic being temporary. This emergency administrative regulation will not be replaced by an ordinary administrative regulation.
201 KAR 2:414E.Ordering and administering vaccinations.
Section 1.
Definitions.(1)
"Administer" is defined by KRS 315.010(1).(2)
"Pharmacist" is defined by KRS 315.010(17).(3)
"Prescribe" means to issue an original or new order from a pharmacist for an FDA-approved or authorized vaccination or medication, including but not limited to, epinephrine, diphenhydramine, and corticosteroids for the emergency treatment of acute vaccine reactions.Section 2.
Pharmacist Requirements.(1)
A pharmacist may administer a vaccine to an individual pursuant to the Advisory Committee on Immunization Practices (ACIP) standard immunization schedule in accordance with KRS 315.010(22).(2)
A pharmacist may administer a vaccine to a child, age three (3) through eight (8), pursuant to a prescriber-approved protocol.(3)
A pharmacist may prescribe and administer a vaccine to an individual eighteen (18) and under, pursuant to the ACIP standard immunization schedule, a seasonal flu vaccine to any individual aged nineteen and over, a COVID-19 vaccine to any individual, and medications necessary for the emergency treatment of acute vaccine reactions, if the pharmacist:(a)
Completes or has completed practical training on administering vaccinations. This may include:1.
Completion of a practical training program from an education provider accredited by the Accreditation Council for Pharmacy Education (ACPE) that includes hands-on injection technique and the recognition and emergency treatment of acute reactions;2.
Graduation from an ACPE accredited pharmacy school in which hands-on immunization training was part of the curriculum; or3.
Training via hands-on experience immunizing in current or previous pharmacy practice; and(b)
Possesses a current certificate in basic cardiopulmonary resuscitation.(4)
No provision in this regulation affects the ability of a pharmacist to administer a vaccination to any individual pursuant to a prescription drug order.Section 3.
Effective Date.(1)
This administrative regulation shall become effective at 5 p.m. on the date it is filed.(2)
In accordance with KRS 31A.190, this administrative regulation shall remain in effect until:(a)
Expiration of the time period established by KRS 31A.190; or(b)
Withdrawn in accordance with KRS 13A.190(12).(3)
The Board of Pharmacy shall regularly consult with the Governor's Office, the Centers for Disease Control and Prevention, and other public health authorities to determine if this administrative regulation shall be withdrawn prior to its expiration under KRS 13A.190.This emergency administrative regulation establishes requirements that the Board of Pharmacy shall implement to comply with 42 U.S.C. 247d-6d, 85 Fed. Reg. 15198, 52136 and 86 Fed. Reg. 9516, 10588,14462 and 41977.These provisions of federal law preempt state law during the public health emergency (PHE). Since March 18, 2020, ten (10) amendments to the Prep Act declaration have been issued, including amendments authorizing pharmacists to prescribe and administer COVID-19 vaccines for individuals as young as three (3). The PHE for COVID-19 ends on May 11, 2023, and under section V(d) and (f) and under section VII(b) of the PREP Act declaration, the expanded authority for pharmacists will expire. This statement of emergency is limited from filing until May 11, 2023. This emergency administrative regulation is necessary, pursuant to KRS 13A.190(1)(a)3 and 4, to ensure continued compliance with federal law and to ensure that Kentucky continues to have an ample pool of pharmacists available to order and administer the COVID-19 vaccine. Without this emergency regulation, many Kentucky-licensed pharmacists would become ineligible to order and to administer the COVID-19 vaccine because they do not meet federal training requirements. So long as the state has a training requirement, compliance with the state training requirement is sufficient to comply with federal law. Without this emergency administrative regulation, there is no state training requirement. An ordinary administrative regulation is not a sufficient avenue to address the current emergency due to the COVID-19 pandemic being temporary. This emergency administrative regulation will not be replaced by an ordinary administrative regulation.